GoLiver Therapeutics Awarded Innovation in Biotherapies & Bioproduction Call for its GOCLINICALS Project Dedicated to Novel Stem Cell-Based Liver Therapy

GoLiver Therapeutics recently announced it has won the Innovations in Biotherapies and Bioproduction call for proposal launched by the French government to make France a European leader in the biotherapy sector. The start-up will receive a €1.6-million investment from France 2030.

GoLiver Therapeutics aims to bring to market the first biomedicine to treat severe acute liver failure and, more broadly, chronic liver disease, without the need for liver transplantation, which is currently the only recognized curative treatment for end-stage liver disease.

The GOCLINICALS project is intended to provide the first clinical proof of tolerance, safety, and efficacy of a new type of cellular biomedicine developed by GoLiver Therapeutics. This innovative therapy has both a unique therapeutic concept and an industrial bioproduction concept.

The young company from Nantes has developed GLTX-001, a biomedicine consisting of an injectable solution of frozen allogeneic liver cells that can be easily and rapidly prepared at the patient’s bedside. GLTX-001 has been proven to be more effective than competing cells in a published preclinical study. It protects the liver from acute and massive destruction of hepatocytes and accelerates its natural capacity to regenerate. Furthermore, GoLiver Therapeutics has successfully solved the challenge of cell therapy, which requires the production of billions of drug cells, with its iMillenium manufacturing platform. Based on pluripotent stem cell technology combined with an innovative concept for liver cell production, iMillenium delivers unprecedented yield and cost-effectiveness. One additional asset is that the platform can be rapidly deployed on the market, as it uses bioreactors that are already marketed and used by CDMOs for advanced cell therapies.

“We are very grateful to France 2030 for supporting us in reaching a major milestone for our first advanced cell drug candidate. The GOCLINICALS project will reveal our technological lead. GoLiver Therapeutics will be the first company to conduct a clinical trial of liver regenerative medicine using pluripotent stem cells. GLTX-001 will be a game-changer for patients suffering from liver disease. The preclinical data is impressive, and the fact that it can be made available immediately, in unlimited quantities and ready-to-use are already factors for its success in routine clinical use. I am confident that GOCLINICALS will demonstrate the incredible therapeutic potential of GLTX-001 in patients. I am really looking forward to seeing GOCLINICALS show the amazing potential of GLTX-001 for patients. This is a federating project that we will involve our long-standing partners, the cell and gene therapy unit (UTCG) of Nantes University Hospital, with whom we have already produced a GMP pilot batch of 15 billion liver cells, and the Paul-Brousse Hospital of the AP-HP (Public Assistance – Paris Hospitals), France’s first liver transplant centre.
Our commitment is to start creating this new healthcare industry in France and to spread this medicine of tomorrow, which will be accessible to all, more affordable and more competitive. While we initially focused on liver disease, we will now be tackling other diseases to bring them the benefits of our advances. This will also be an opportunity to diversify our portfolio. We hope that this new recognition from the French government will bring us the support of investment funds to accelerate the scale-up of our company,” said Tuan Huy Nguyen, President of GoLiver Therapeutics.

Today, around 800 million people suffer from chronic liver disease. Liver failure is responsible for over 2 million deaths, and only 30,000 liver transplants are performed each year worldwide. To overcome these challenges, GoLiver Therapeutics is harnessing the inherent ability of patient’s own liver cells to regenerate into a new liver boosting by a cell drug whose pharmaceutical bioproduction is mastered in terms of quality and quantity on a large scale, which is currently a major gap.

GoLiver Therapeutics is a spin-off from Inserm and the University of Nantes (now Nantes University), created in 2017. It is focused on the development of advanced therapy medicinal products to meet an urgent unmet medical need in transplantation. GoLiver Therapeutics aims to become a world leader in the field of regenerative medicine by tackling liver regeneration, by conducting the first clinical trials and bringing to market the first innovative cell-based drug for the treatment of liver disease without the need for transplantation, using the breakthrough technology of pluripotent stem cells.

Winner of France Relance in 2021, the start-up was awarded the Seal of Excellence of the European Union in 2023, identified by Challenges magazine as one of the ‘100 start-ups to invest in’ in 2019, GoLiver Therapeutics was awarded the France French Transfer Invest 2019, the i-LAB 2016 national Grand Prize in healthcare biotechs and i-LAB ‘Emergence’ start-up contest 2015. Its R&D is supported by the European Regional Development Fund (ERDF) of the Région Pays de la Loire (2018, €400k), followed by a funding from the «Recovery plan for industry – strategic sectors» (2021, €1 million), aimed at implementing the first production line for its biomedicine in France. For more information, visit https://golivertx.com/.